The aim of this study was to evaluate the safety and efficacy of supCD7 CART cells in the treatment of patients with relapsed/refractory CD7-positive hematologic malignancies. In this single-arm, open-label, single-center, Phase Ⅰ+Ⅱ clinical trial, two cohorts were set up: (1) relapsed and refractory AML cohort; and (2) relapsed and refractory T-ALL/LBL cohort. Each cohort was planned to enroll 4-12 patients. SupCD7 CART cells will be administered intravenously to explore the MTD of each cohort using a 3+3 dose escalation and rapid titration design.
This study will use super-universal CD7 CART cells to treat CD7-positive relapsed or refractory hematological malignancies, especially AML and T-ALL/LBL patients. Two cohorts were established: (1) relapsed and refractory AML cohort; and (2) relapsed and refractory T-ALL/LBL cohort. A 3+3 dose escalation and rapid titration design was used to explore the MTD for each cohort. 3+3 dose escalation CART cells dose groups were (1) 0.5×10\^6 CART cells/kg; (2)1×10\^6 CART cells/kg;(3) 3×10\^6 CART cells/kg. A minimum of 4 and a maximum of 12 patients are expected to be enrolled. Fludarabine and cyclophosphamide-based preconditioning should be performed within 1 week prior to supCD7 CART cells infusion. supCD7 CART cells can be infused at D-1 if the requirement of 24 hours after completion of preconditioning is met. To evaluate the safety and efficacy of supCD7 CART cells in the treatment of patients with relapsed/refractory CD7-positive hematologic malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Subjects screened to meet the requirements for supCD7 CART cells use will enter clinical trials. Subjects were assessed at baseline. Fludarabine and cyclophosphamide based preconditioning should be performed within 1 week prior to supCD7 CART cells infusion: fludarabine (Flu) 30mg/m2 ×3 days; cyclophosphamide (CTX) 500mg/m2 ×3 days. The investigator can adjust the pretreatment regimen appropriately according to the condition of the subject, such as increasing the dose of CTX to 600mg/m2 ×3 days, increasing the application of cytarabine and VP-16. Infusion of supCD7 CART cells must be performed 24 hours after completion of chemotherapy preconditioning. supCD7 CART cells can be infused at D-1 if the requirement of 24 hours after completion of preconditioning is met.
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGOverall Response Rate (ORR)
1. The proportion of patients achieving CR (complete remission) or CRi (complete remission with incomplete hematologic recovery) for T-ALL/LBL. 2. The proportion of patients achieving CR, CRi, or PR (partial remission) for T-ALL/LBL. 3. The proportion of patients achieving CRc \[composite complete remission, including CR/CRh (complete remission with partial hematologic recovery)\] or CRi for AML.
Time frame: Efficacy will be evaluated at Weeks 4, 8, and 12 following supCD7 CART cell infusion.
Total MRD-negative response rate (MRD-ORR) in bone marrow after supCD7 CART cell infusion
The proportion of patients achieving CR/CRi (T-ALL/LBL) or CRc (AML) who are MRD-negative in the bone marrow.
Time frame: 3 months after supCD7 CART cells infusion
Duration of remission (DOR)
The time from first achieving CR/CRi + PR (T-ALL/LBL) or CRc + PR (AML) after supCD7 CAR-T infusion to disease relapse or death due to leukemia.
Time frame: Participants will be followed for the duration of the treatment, an expected average of 24 months
Event-free survival (EFS)
The time from supCD7 CAR-T infusion to the earliest occurrence of any of the following events: death from any cause after remission, relapse, no response to treatment, or treatment discontinuation due to leukemia- and/or treatment-related death, adverse events, or initiation of new anti-tumor therapy (excluding bridging transplantation).
Time frame: Participants will be followed for the duration of the treatment, an expected average of 24 months.
Leukemia-free survival (LFS)
The time from first achieving CR/CRi (ALL/LBL) or CRc (AML) to relapse or death.
Time frame: Participants will be followed for the duration of the treatment, an expected average of 24 months.
Proportion of patients undergoing hematopoietic stem cell transplantation (HSCT) in remission
The proportion of patients who receive HSCT among those achieving remission after infusion.
Time frame: Participants will be followed for the duration of the treatment, an expected average of 24 months.
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